News and updates on potential cures for type-1 diabetes, that are in human (or clinical) trials.

Wednesday, November 18, 2009

Xoma Starts a Phase-II Human Trial

My local JDRF chapter is setting up a "Research Information Committee" to help spread the word about type-1 diabetes research, and I was asked to be a member. We had our first meeting a few days ago, and one of the other members mentioned the following human trial was just getting started:

Xoma Starts a Phase-II Human Trial

Xoma is starting a phase-II clinical trial of their "Xoma 052" drug.

The study is placebo controlled and double blind, and the primary end-point is C-peptide levels (so good design). It is being done in Zurich and I'm not sure how many people will be enrolled. Only people who have had type-1 diabetes for 2 years or longer will be enrolled. So this is not a honeymoon study: quite the opposite; honeymoon diabetics are excluded.

There are already two separate phase-I clinical trials underway to see if Xoma 052 improves type-2 diabetes. (I assume that is why they could go directly to phase-II trials in type-1 diabetes: the basic safety was already established.) Xoma inc. is also doing animal research to see if this drug can be used for many other inflammation related diseases, such as rheumatoid arthritis and gout.

This clinical trial is being funded by JDRF.

Xoma 052 is a monoclonal antibody which is a broad anti-inflammatory, and works by blocking the IL-1 inflammation pathway. Xoma is in the business of developing monoclonal antibodies which are then marketed by much larger companies. They already have a couple of drugs on the market.

Discussion

Earlier this year (and in 2008) there was some excitement about inflammation based treatments as cures for type-1 diabetes. The idea as that the body's autoimmune response triggered inflammation and it was the inflammation which actually killed the beta cells. So lowering inflammation could cure or prevent type-1 diabetes. This is a minority opinion, to be sure. Most researchers believe that inflammation is a side effect of the beta cells being destroyed, not a cause of their destruction. This trial is the third one, that I know of, based on the idea that anti-inflammatories can cure type-1 diabetes.

One of the best things about this research, is that they expect results next year, and as a phase-II trial, it should be big enough, so that the results should be pretty clear as to the basic success of the drug. We should have a basic "thumbs up / thumbs down" result by the end of 2010. Another good thing, from my point of view, is that this is not a honeymoon only treatment or trial.

Personally, I'm a little dubious about the whole "anti-inflammation as a cure" path. But I'm also very data-driven, and we now have 3 different studies going on to try to cure type-1 using this path. If any one of those studies gives successful results, then all my doubts will be erased. :-)

Xoma's press release:http://www.xoma.com/company/news-events/press-releases/index.cfm?releaseID=421746Clinical trials record for this research:http://www.clinicaltrials.gov/ct2/show/NCT00998699Clinical trials records for Xoma's other diabetes research:http://www.clinicaltrials.gov/ct2/results?term=xoma+diabetesPrevious blog entry on inflammation (including some general discussion):http://cureresearch4type1diabetes.blogspot.com/2009/04/two-new-trials-to-test-kineret-anakinra.html

All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.

4 comments:

Anonymous
said...

Did you read about the accidental medical breakthrough with the Interleukin-1 beta (IL-1β) gene and Alzheimer’s disease? XOMA is very secretive http://www.sciencedaily.com/releases/2009/10/091022114315.htm

I don't know what you mean by "very secretive". I got my information from a press release (very public). They filed the Clinicaltrials paperwork to start their trial on Oct-22, and discussed it publicly on Nov-4. I don't see how that is secretive at all.

Well...The scientific community was very skeptical that a Bacteria could be the causative agent of many cases of Petic Ulcer Disease i.e., Heliobacter pylori. The 'Scientific Community" went on to eat 'Crow" for that opinion and the researcher who hypothesized and later proved the connection went on to win the Nobel Prize in Medicine if I'm not mistaken. So inflammation in Type 1 diabetes? The Scientific Community has been proven wrong before.

In the past 15 years, innate immunity has come into its own. Inflammation, its hallmark characteristic, has gained recognition as an underlying contributor to virtually every chronic disease a list that, besides obvious culprits such as rheumatoid arthritis and Crohn’s disease, includes diabetes and depression, along with major killers such as heart disease and stroke. The possibility of a link with a third major killer cancer has received intensive scrutiny in this decade. The connection between inflammation and cancer has moved to center stage in the research arena, notes Robert A. Weinberg of the Massachusetts Institute of Technology’s Whitehead Institute for Biomedical Research, who has highlighted the changing emphasis in a revision of his leading textbook, The Biology of Cancer (Garland Science, 2006).

My Most Important Posts

Follow by Email

This blog discusses cures and preventatives for type-1 diabetes that are either in human trials or just about to start. Treatments for diabetes are not generally discussed here, unless they can turn into a cure or a preventative. My definition of a cure is this:1. Blood sugar control without testing and with doctor's visits 4 times a year, or less. Any cure must result in an average lifespan close to normal.2. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)Obviously, this is my personal definition of a cure; yours may differ.Because a cure for type-1 diabetes is likely to involve a combination of several different drugs or treatments, I try to follow research into anything which may be an important part of the cure.

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).

I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.

I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.

None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)

My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.

I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.

In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.